MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND HUMERAL SPACER +9MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL SPACER

Catalog Number	130730009
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that poly did not lock into the spacer so users replaced both the poly and the spacer.The doctor was able to pull it out with his two fingers after impacting it.Doe: (b)(6), 2025 affected side: right shoulder.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9, d10 (concomitant).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > it was reported that poly did not lock into the spacer so users replaced both the poly and the spacer.The doctor was able to pull it out with his two fingers after impacting it.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the dxtend humeral spacer +9mm does not show signs of any nonconformance that would contribute to the reported complaint.Evidence indicates that the device had been properly measured and inspected at the manufacturer through a 100% inspection process.All relevant dimensional checks and specifications were found to be within acceptable limits at the time of release.Consequently, there is no indication of any manufacturing error that could have contributed to the reported issue.Furthermore, the delta xtend¿ reverse shoulder system surgical technique care notes (pages 41) can be reviewed for further assessment.The overall complaint was not confirmed as the observed condition of the dxtend humeral spacer +9mm would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > a manufacturing record evaluation was performed for the finished device product description: dxtend humeral spacer +9mm product code: 130730009 lot number: 5556230 and no non-conformances or manufacturing irregularities were identified.Device history review = > a manufacturing record evaluation was performed for the finished device product description: dxtend humeral spacer +9mm product code: 130730009 lot number: 5556230 and no non-conformances or manufacturing irregularities were identified.Corrected: h3.

• Brand Name: DXTEND HUMERAL SPACER +9MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL SPACER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22675574
• Report Number: 1818910-2025-13373
• Device Sequence Number: 18429198
• Product Code: HSD
• UDI-Device Identifier: 10603295027348
• UDI-Public: (01)10603295027348(17)280630(10)5556230
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 130730009
• Device Lot Number: 5556230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 10/06/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/06/2025; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DXTEND STAND PE CUP D42 +9MM.
• Patient Sex: Unknown